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Researchers have made progress in developing a "bionic pancreas" that holds promise in helping Type 1 diabetic patients better manage their blood sugar than with an insulin pump. This may help patients prevent potential life-threatening complications.

The wearable bionic device, showcased recently at the American
Diabetes Association meeting in San Francisco, Calif., uses iPhone app that lets patients enter information immediately prior to
eating. Every five minutes the app receives a blood sugar reading
from an attached continuous glucose monitor, which it uses to calculate
and administer a dose of either insulin or glucagon.

Researchers
from Boston University (BU) and Massachusetts General Hospital (MGH)
reported the results from two clinical trials in The New England Journal of Medicine.
The study included one trial for adults and one for adolescents. Both trials imposed minimal restrictions on patients’
activities.

Type 1 diabetes is usually diagnosed in children and
young adults. According to the U.S. Centers for Disease Control and
Prevention, 29.1 million people, or 9.3 percent of the population, have
diabetes. The American Diabetes Association states that five percent of
people with diabetes have type 1 diabetes.

In type 1 diabetes, the
body does not produce insulin, a hormone needed to convert sugar,
starches, and other food into energy needed for daily life.

Study Compared Device with Patients' Use of Insulin Pumps

Both
studies compared data showing five days on the bionic pancreas system
with five days of participants' usual care using their own insulin
pumps. The adult trial enrolled 20 participants who lived at home and
managed their own care during the usual-care period. The adolescent
trial enrolled 32 participants, ages 12 to 20, attending a camp for
youngsters with type 1 diabetes, who followed the same activity and meal
schedule as other campers during both phases of the trial.

Pointing
out that his 15-year-old son was diagnosed with diabetes when he was 11
months old, Edward Damiano, Ph.D., associate professor at the BU
Department of Biomedical Engineering, principal investigator of the
project, and a senior author of the NEJM report, told
Healthline, "The benefit to patients of a device like this is to offer
them much better glucose control that will keep them healthier for many
years. The glucose control we saw, that this device was able to achieve,
is consistent with a level of glucose control that should stave off
long-term complications of diabetes, and at the same time protect them
from the dangers of low blood sugars."

Diabetics Face Problems

Noting that diabetics face
two problems, Damiano said, "There are long-term complications of
running your blood sugars too high and then people strive to lower them
with standard care therapies. But the challenges there become, as you
add more insulin to do that, you run the risk of exposure to low blood
sugars. Our device achieves very safe long-term blood sugars, and at the
same time reduces episodes of the low blood sugars."

Emphasizing
that the device used in the studies is an investigational device,
Damiano said, "The final version of the device will run on a dedicated
piece of medical device hardware. We are just using the iPhone as a
portable computer for the purposes of this study."

Damiano also
said the device conveys "an enormous emotional benefit in unburdening
the stress that goes along with constantly having to manage this
relentless disease. Diabetics are constantly in fear of low blood sugar,
especially at nighttime."

Co-lead author of the report, Firas
El-Khatib, Ph.D., of the BU Department of Biomedical Engineering, said
in a press statement, "One of the key virtues of this device is its
ability to start controlling the blood sugar instantly, based only on
the patient's weight, and continually adapt its decision-making
regarding insulin and glucagon dosing to handle a wide range of dosing
requirements."

Future Studies

Damiano
and El-Khatib published a 2010 Science Translational Medicine report in
which a first-generation system was successful in controlling the blood
sugar of adults for 27 hours. That study was conducted in a controlled
hospital inpatient environment where participants remained in bed for
the whole period and ate prescribed meals.

"The key element with
the current version of this device is that it's wearable, allowing
participants to stay in something close to their usual environments,
exercise, and eat whatever they want," said Dr. Steven Russell, Ph.D.,
of the MGH Diabetes Unit, who led the current clinical trials.

Two
follow-up trials are already underway. One of these trials is a
home-study-only, and it requires participants to stay within an hour's
drive of the study site. That trial will compare 11 days on the bionic
pancreas with 11 days of usual care. The second study will enroll
children ages six to 11, and is currently enrolling participants already
registered at the camps. Information on both of those trials is
available at http://www.bionicpancreas.org/.